Cleared Traditional

K160855 - U&U Enteral Syringe

K160855 is an FDA 510(k) clearance for U&U Enteral Syringe, manufactured by U&U Medical Technology Co, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code PNR cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K160855 · U&U Medical Technology Co, Ltd. · Gastroenterology & Urology device
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Nov 2016
Decision
239d
Days
Class 2
Risk

K160855 is an FDA 510(k) clearance for the U&U Enteral Syringe. Classified as Enteral Syringes With Enteral Specific Connectors (product code PNR), Class II - Special Controls.

Submitted by U&U Medical Technology Co, Ltd. (Changzhou, CN). The FDA issued a Cleared decision on November 22, 2016 after a review of 239 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all U&U Medical Technology Co, Ltd. devices

FDA 510(k) Submission Details - K160855

510(k) Number K160855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2016
Decision Date November 22, 2016
Days to Decision 239 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 131d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNR Device Classification - Class 2, Special Controls

Product Code PNR Enteral Syringes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition Delivers Nutrition, Medication, Or Hydration Orally Or To A Gastrointestinal Tube Or Extension Set Using Aami/cn3(ps):2014 Compliant Connectors.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PNR Enteral Syringes With Enteral Specific Connectors

All 34
Devices cleared under the same product code (PNR) and FDA review panel - the closest regulatory comparables to K160855.
ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
K161141 · Pentaferte Italia S.R.L. · Mar 2017
ENFit enteral syringe
K161979 · Jiangyin Caina Technology Co., Ltd. · Mar 2017
Medela Low Dose Enteral Syringe
K161811 · Medela, Inc. · Feb 2017
Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)
K162188 · Vr Medical Technology · Sep 2016
Monoject Enteral Syringe with ENFit Connector
K161963 · Covidien · Sep 2016
NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
K161039 · Neomed, Inc. · Jun 2016